Balance Therapeutics is evaluating an investigational new drug BTD-001, to treat excessive daytime sleepiness in individuals diagnosed with Idiopathic Hypersomnia (IH) or Narcolepsy Type 2 (Na-2). A Phase 2 clinical trial is currently enrolling Na-2 subjects at 26 investigational centers in the United States. Individuals currently diagnosed as “IH” who may have previously been diagnosed as narcolepsy may also qualify. For more information regarding the study and participating site locations, and if you are interested in participating in this trial, please visit the website: www.arisestudies.com

Background:

Recent research published by a research team from Emory University in Atlanta, Georgia has demonstrated that the excessive daytime sleepiness in many individuals diagnosed with Idiopathic Hypersomnia (IH) and Narcolepsy Type 2 (narcolepsy without cataplexy; Na-2) is driven by accumulation of a naturally occurring substance, yet to be identified, that increases the function of the sleep promoting neurotransmitter γ (gamma)-amino-butyric acid (i.e., GABA) in the brain.

The investigational drug BTD-001 is known to suppress GABA activity. BTD-001 is therefore targeted more directly at emerging mechanisms thought to cause the excessive sleepiness of many patients diagnosed with IH and Na-2. It is also unique from current FDA approved therapeutic approaches for alleviating the excessive daytime sleepiness in individuals diagnosed with IH and Na-2.

To learn more information about the clinical trial and see if you might qualify, please visit the website: arisestudies.com

HF urges the entire hypersomnia community, including people with IH, people with narcolepsy, all supporters and healthcare professionals, to take a short survey prepared by Project Sleep in partnership with the University of Arizona “to capture perspectives of the narcolepsy and hypersomnia community.”

Julie Flygare of Project Sleep notes, “…we hope it will be useful to help illustrate to the sleep researchers what PATIENTS’ research priorities are and how they may differ from their preconceived notions of what’s important – and hopefully spark some new collaborations between patient leaders and organizations and researchers.”

After we posted the link on our HF Facebook page, followers weighed in on the survey, commenting that it takes only about ten minutes to complete. Note that the deadline for completing the survey is May 17th.

Social Security Disability Series: Part 2

Sleep Disorders and Social Security Disability – What You Need to Know

By Anjel Burgess, JD

Jennie has been fortunate enough to secure her short-term disability benefits. She has also hired an Attorney to assist her with the Social Security Disability application process. Although her family encouraged her to “file on her own instead of paying out of pocket to hire an attorney,” Jennie has learned throughSomnusNooze that Social Security Disability attorneys are not paid by a retainer, as many attorneys are. Rather, they work on a contingency basis, which means that Jennie does not have to pay out of pocket to get representation. For the attorney to get paid, two conditions must be met:

The attorney must win Jennie’s case.

Jennie must be entitled to past-due benefits (also known as back pay).

If both conditions are met, the Social Security Administration (SSA) will pay Jennie’s attorney 25% of Jennie’s back pay, up to a maximum of $6,000. Since obtaining the benefits is of the utmost importance to Jennie, she has decided that she can’t afford NOT to have an attorney. She has hired an attorney who will file an initial application for her and represent her through each step of the process.

Jennie’s attorney has explained to her that most people who receive Social Security Disability benefits have been through a three-step process and that it may take two years or more before she is approved (note that in some states, it is a 2-step process, as the Reconsideration step is eliminated). These steps include the following.

Initial – Roughly 30% to 35% of applicants are approved at this level. Once SSA receives the initial application, they request medical records from Jennie’s providers. Once the SSA receives Jennie’s medical records, SSA will have its own physician or psychologist (or both a physician and psychologist) review the medical records to give their opinion as to what limitations they believe that Jennie has, as well as the impact of those limitations on her ability to work. This would also include a review of the opinion of Dr. Wonderful and any other of Jennie’s treating physicians. Oftentimes, SSA will decide that they need an outside opinion in making their decision. If this occurs, the SSA may require that Jennie be examined by an independent physician or psychologist (at SSA’s expense) who may not have an expertise in idiopathic hypersomnia. This independent professional then prepares a report that summarizes her or his observations and professional opinion. If the case is denied initially, Jennie can appeal.

Reconsideration – Roughly 7% to 10% of applicants are approved at this level. At the Reconsideration step, SSA obtains updated medical records and completes another internal review of Jennie’s file to see if any new evidence would result in a favorable outcome. It is possible that the SSA may send Jennie out for an independent examination at this stage as well. Again, if Jennie is denied, she can appeal.

Hearing – Roughly 50% to 55% of the remaining applicants are approved at this level. This is the stage at which most people are awarded benefits, particularly after attending a hearing in front of an administrative law judge. The hearing is the opportunity for Jennie and her attorney to present the big picture to a judge. The big picture includes all medical records and testimony from Jennie herself. Jennie’s attorney will also have the opportunity to make oral and written arguments on Jennie’s behalf.

The common theme in each step of the process is medical records. Medical records are vital in a disability case because they can provide objective support for an individual’s complaints. For Jennie, her medical records tell the story of a very symptomatic individual who tried multiple medications but could only be productive for about 3 hours throughout the day. Her doctor ruled out many other conditions, and was able to confirm the diagnosis of idiopathic hypersomnia via a polysomnogram and Multiple Sleep Latency Test. Jennie’s medical records provide proof that she has idiopathic hypersomnia and authenticate her symptoms, which are reasonably due to idiopathic hypersomnia.

If you, too, are ready to file for Social Security Disability or have been denied at any step in the process, contact a qualified Social Security Disability Attorney to assist you with the process.

Anjel Burgess is a partner/attorney at the Law Firm of Burgess and Christensen located in Marietta, GA. She exclusively practices Social Security Disability Law for adults and children, as well as the ancillary areas of Guardianships and Special Needs Trusts. By doing so, she has been able to make a positive difference in the daily lives of people who need help the most. You may reach her at Anjel@DisabilityHelpLine.com or 770-422-8111. You can learn more about her services at www.DisabilityHelpLine.com

Have you joined the registry yet?

A patient registry is a collection that is established to collect standardized information about a group of patients who share a common condition or experience. In the case of the Hypersomnia Foundation Registry at CoRDS (Coordination of Rare Diseases at Sanford), the people who participate have one of the central disorders of hypersomnolence: idiopathic hypersomnia, Kleine-Levin syndrome, or narcolepsy (type 1 or 2). Becoming part of the registry is easy and it could help solve the puzzle of hypersomnia! Simply go to http://www.sanfordresearch.org/cords/ and click on the ENROLL NOW button.

The Hypersomnia Foundation Board of Directors is thrilled to announce the launch of the Hypersomnia Foundation’s Registry at CoRDS (Coordination of Rare Diseases at Sanford). Whether you have idiopathic hypersomnia, Kleine-Levin syndrome or narcolepsy type 1 or 2, please enroll in the Registry today to help solve the puzzle of hypersomnia. Your information will help researchers comprehend the journey that people with hypersomnia travel in their search for a diagnosis and will answer many other questions, including the symptoms that you experience, which may help to distinguish among these disorders, and the treatments that have and have not worked for your symptoms. Registration is simple (the second figure below describes the process). Simply go to http://www.sanfordresearch.org/cords/ and click on the ENROLL NOW button. Your answers to the Registry questions will help researchers design better diagnostic tools and more effective treatments and, eventually, find a cure. CoRDS personnel are available to help you, if needed, during the registration process. They can be reached at cords@sanfordhealth.org or 1 (877) 658-9192.

What is a Registry?A patient registry is a collection that is established to collect standardized information about a group of patients who share a common condition or experience. In the case of the Hypersomnia Foundation Registry at CoRDS, the people who participate have one of the central disorders of hypersomnolence: idiopathic hypersomnia, Kleine-Levin syndrome, or narcolepsy (type 1 or 2).

Very recently, the Hypersomnia Foundation became aware of an opportunity to help shape the future of sleep research. The National Institutes of Health, the primary source of funding for medical research in the United States, has issued a Request for Information, which you can view at: https://grants.nih.gov/grants/guide/notice-files/NOT-HL-16-312.html.

The final date to submit your comments has been extended to today, May 16, 2016.

Last week, we sent an email to everyone in our database to encourage you to make your voices heard. We are urging you again to act today. Please share your hypersomnia story with the people who determine medical research priorities and allocate funds.

Tell them why the currently available diagnostic tools and lack of awareness about hypersomnia led to a lengthy delay in your diagnosis.

Tell them why research into the cause of and effective treatments for hypersomnia are so desperately needed.

Tell them why we need a cure as soon as possible because hypersomnia is limiting your ability to achieve your dreams, complete your education, or even provide financially for your family.

Please join your voice with ours as we fight to secure the place of hypersomnia at the top of the nation’s sleep research agenda. The Hypersomnia Foundation Board of Directors has submitted the following response, and we encourage you to send your comments and suggestions to the NIH, as you deem appropriate, at rfi-sleepplan2016@collaboration.nhlbi.nih.gov.

Hypersomnia Foundation Response
to the National Institutes of Health’s Request for Information:

For nearly a century, the study of sleep and its function(s) in health and disease has been principally focused within approaches that center on not enough sleep. Although excessive daytime sleepiness (EDS), cognitive dissonance, and other symptoms not surprisingly result from sleep deprivation, central disorders of hypersomnolence (CDH; e.g., idiopathic hypersomnia, Kleine-Levin syndrome,narcolepsy type 1 [NT1], and narcolepsy type 2 [NT2]) in humans (in which EDS is often accompanied by extremes of sleep length) emerge spontaneously. Studying patients with CDH has already proven to be fertile ground for investigation, as evidenced by the discovery that loss of brain hypocretin causes narcolepsy withcataplexy (i.e., NT1). Yet, for the other CDH, there remains a large unmet clinical need, with further research and development prime for discovery and the potential for extraordinary translational opportunities.

Symptoms of CDH can be disabling, and because, for example in NT1, they also begin in adolescence or young adulthood, are chronic, sometimes progressive, go undiagnosed or misdiagnosed for decades, and respond variably to medications.
Despite advances around NT1, the knowledge gained has not translated smoothly to
the clinical realm. Diagnoses of CDH inclusive of NT1 since 1975 have relied upon a
forty-year-old test (viz., the Multiple Sleep Latency Test [MSLT]) that is cost, time,
and labor intensive and that was born of practical necessity and subsequently
tweaked to specifically identify NT1. In 2006, two preeminent sleep researchers concluded that the MSLT yields “a large number of false-positives” and that an increased daytime propensity to REM-sleep—traditionally accepted to be the sole domain of NT1—does “not appear to have any specific pathognomonic significance.” Yet, in 2016, the MSLT remains the gold standard that drives diagnoses and all that it implies. For clinician scientists, this means, for example, how clinical trials are designed and studies of heritability are conducted. Even more so, for patients, this has enormous implications for prognosis, treatment choice, access to medication(s), and accommodations/disability status.

There are currently no FDA-approved treatments for the CDH—medication choice being limited to those for narcolepsy. Since the 1930s, conventional
psychostimulants such as ephedrine have been used to treat NT1. The majority of the current pharmacological armamentarium and drug development are similarly designed and focused upon promoting wakefulness by enhancing brain monoamines. Drugs more directly designed to replace hypocretin continue in development 16 years after the discovery of hypocretin. An alternative construct in approaching the biology and treatment of CDH has recently been proposed that appears to hold great promise for many patients. People with CDH without NT1 (i.e., hypocretin being intact) do not appear to suffer from any “loss of function” per se but, rather, a gain of function in sleep-promoting brain circuits. Thus, pharmacologic agents that antagonize the sleep-promoting and consciousness-dampening neurotransmitter gamma–aminobutyric acid (GABA), such as flumazenil, clarithromycin, and pentylenetetrazol, have either been demonstrated to be effective or are in clinical trials for CDH patients in whom traditional wake-promoting agents have not been helpful.

We advocate for initiatives to fund discovery research that translates to improve the human condition of people with CDH in whom sleep is prolonged and ostensibly persists into “wake.” Enhanced recognition and improved treatments call for greater understanding of not only the clinical spectrum of CDH and the natural history of these disorders, but also mechanistic understanding of their biological underpinnings. Diagnostic tools that are highly discriminative and designed to capture more than just EDS and an increased daytime propensity to REM sleep are an absolute necessity. CDH remain diagnoses of exclusion such that greater understanding of potential mimics—which themselves would enhance mechanistic understanding of sleep—and biomarker discovery are also high priorities. As there are numerous stakeholders in such endeavors, as evidenced in the summary provided above, the absolute need to encourage greater dialogue and collaboration among patients, patient advocacy groups, professional organizations representing sleep physicians, funding agencies, and industry cannot be understated. With increasing dissemination of knowledge through many means, not the least of which includes social media, patient consumers with CDH-like symptoms have become increasingly knowledgeable. They are acutely aware that CDH outside the realm of NT1 is not well served by current medical knowledge or practice in this realm. Accepting the status quo risks alienating the public and medical consumer.

We would, therefore, propose including a sleep neurobiologist on the NHLBI Sleep
Disorders Research Advisory Board and developing mechanisms for solicitation of
program projects and set-aside funds specifically to research hypersomnia, with requests for proposals to prioritize filling unmet clinical needs in the following areas:

Because the breadth of scientific inquiry or line of investigation needs incredible resources and sustainability, we would advocate for funding initiatives with set-aside monies at all levels of training, including predoctoral, doctoral, postdoctoral, junior investigator, and senior investigators, and we envision promoting set-aside monies for all the Career Development K Awards for investigators with projects relevant to CDH.

Learn about the latest hypersomnia research on June 12th at the Hypersomnia Foundation’s regional conference, Beyond Sleepy in the Mile High City. Scientists will share findings from their recently completed clinical trials and other ongoing studies, lead us on a journey through the drug discovery and approval process, and help us to cope with the daily struggles of hypersomnia. You will also learn how your future participation in the registry can help to solve the puzzle of hypersomnia.

Tickets are running out so order your $25 ticket online to join us in person in Denver or wait until June 1 to sign up for a live Internet stream of the conference, brought to you free of charge through the generous support of Balance Therapeutics, Inc., and Flamel Technologies, SA.

If you haven’t made your plans yet to attend the Hypersomnia Foundation’s regional conference in Denver—Beyond Sleepy in the Mile High City—you might want to do so today. Tickets are selling fast and seating is limited. The big event is in less than seven weeks! A registration link and additional information are available on the Hypersomnia Foundation website, or you can click on the ticket image below to go straight to the registration site.

Wondering whether it’s going to be worth the trip to Denver? Well, wonder no longer. Whether you’re flying across country or driving down the mountain, this meeting offers plenty of time to network and socialize in addition to hearing some fantastic speakers. Remember, attending in person is the only way for you to participate in the question-and-answer session with the experts.

SCHEDULE OF EVENTS

Saturday evening, June 11, from 6:00 to 10:00 pm—Join us in the Atrium Alcove on the fourth floor of the Embassy Suites Hotel 1420 Stout Street, Denver, CO. Catch up with old friends and meet new people as we play board and card games or just spend some time in conversation.

Sunday morning, June 12, from 7:30 to 10:30 am—Join us for a hot made-to-order breakfast at the Embassy Suites Hotel and grab a spot at one of the tables we will have reserved. Don’t worry if you’re not up at 7:30; we’ll save you a place to join us later. (Breakfast is free if you are a guest at the Embassy Suites Hotel and $20 if you are not).

Sunday morning from 10:00 am to noon—Join us to pick up your name badge at registration on the third floor in the Crestone foyer at the Embassy Suites Hotel. Didn’t have enough time to socialize on Saturday evening? We will have a designated gathering space available during this time. Be sure to eat before coming to the conference. We will not be serving lunch.

Sunday afternoon from noon to 5 pm—Join us in the Crestone Salon B meeting room on the third floor of the Embassy Suites to hear six scientific presentations covering the latest on hypersomnia research and how to cope with hypersomnia through the use of behavioral sleep medicine, as well as other fabulous topics. Listed below are the speakers and their topics.

If, like me, you have hypersomnia, I’m sure you’re no stranger to napping wherever it’s convenient: in class, at a stoplight, under your desk, in a library, in a corner at the bookshop, at a table in the cafeteria, in an empty conference room… this is the reality for so many of us. Heck, as a child, I mastered napping on the mat outside my shower and eventually transitioned to actually napping IN the shower before school. My mother couldn’t figure out what was taking me so long and why our water bill was so high. (Of course as an environmentally responsible adult, I feel terrible about all of that wasted water.)

Having finely honed our napping skills, we now have the opportunity to put them to great use and win some pretty cool prizes. Arianna Huffington’s Sleep Revolution has launched an Instagram contest called “Where Do You Nap?” To enter, simply:

Post a picture on Instagram of your favorite napping spot.

Include the contest’s TWO MANDATORY HASHTAGS – #SleepRevolution &#Contest.

To help raise awareness of hypersomnia, please also include the hashtag #BeyondSleepy.

Eighteen people will win Marriott gift cards and a voucher for round-trip travel on Jet Blue. Drawings will take place on various dates, and only legal US residents are eligible to win prizes. To check out all of the rules and more information on prizes and how to enter the contest, visit http://ariannahuffington.com/contest-rules

Background

Compared with adults with narcolepsy, children with narcolepsy often have higher levels of excessive daytime sleepiness (EDS), are more likely to have cataplexy without a trigger, and are more likely to have a secondary form of narcolepsy. The EDS and disturbed night-time sleep of narcolepsy may lead to reduced quality of life and lower academic performance because of the associated obesity, depression, and attention-deficit/hyperactivity disorder (ADHD) that often accompany narcolepsy. ADHD has two main types of symptoms–inattention (such as trouble paying attention or organizing tasks or being easily distracted) and hyperactivity-impulsivity (such as fidgeting or trouble staying seated or waiting for a turn). Other research has shown that adults with narcolepsy have ADHD at a higher rate than the typical adult population, but no one has studied this in children.

Who were the participants and what did they do?

All children with narcolepsy who were seen at one of the national narcolepsy centers in France over a four-year period were invited to participate in this study. Children with narcolepsy (86 with cataplexy [NwC] and 22 without [Nw/oC]) and children without narcolepsy (67 control subjects) were recruited. With the help of their parents if necessary, these children completed several questionnaires, including the Pediatric Daytime Sleepiness Scale, Chalder Fatigue Scale, the ADHD Rating Scale, and the Children’s Depression Inventory.

Who were the researchers and what did they do?

The researchers were physicians from the four national narcolepsy centers in France. They examined each of the participants, calculated the subjects’ body mass index (weight divided by height, in meters squared), and prescribed treatment for narcolepsy for those subjects who had narcolepsy. They did not specifically treat the symptoms of ADHD, although many of the wake-promoting treatments for narcolepsy are also used for ADHD. They reviewed the patients’ responses to the questionnaires.

What were the results of the study?

The children ranged in age from 6.5 to 17.9 years. The children with Nw/oC were, on average, younger that those in the other two groups. Slightly more than half of the children with narcolepsy were overweight, as compared with 10% of the control subjects. About 20% of patients with narcolepsy were obese, compared with 4% of the control subjects. Of the control subjects, 5% to 6% had clinically significant ADHD symptoms, as did 30% of patients with NwoC and 15% of patient with NwC. Those with higher levels of ADHD symptoms had higher rates of depression and decreased quality of life.

With regard to medications, 73% of children with Nw/oC were receiving treatment (> 90% with stimulants, none with sodium oxybate) and 67% of children with NwC were receiving treatment (>90% with stimulants, 14% with sodium oxybate). “Moreover, in contrast to narcolepsy symptoms, for which some benefit of therapy was observed, ADHD symptoms appeared to be largely unresponsive to psychostimulant therapy. It remains unclear, therefore, whether psychostimulant therapy is effective for ADHD symptoms in pediatric narcolepsy and whether hypersomnias and ADHD may or may not share a common underlying pathophysiology.”

Reviewed by Dr. Isabelle Arnulf.

A study of clarithromycin in the treatment of GABA-related hypersomnia indicates that this drug may be effective in some patients with idiopathic hypersomnia (IH), narcolepsy without cataplexy, and subjective hypersomnia.

Background

The US Food and Drug Administration (FDA) has not approved any drugs for the treatment of IH. Therefore, current treatments are all prescribed off label, meaning that the FDA has approved the drug for some other purpose but not for IH.

The researchers then tested a treatment to counteract these sleep-enhancing effects in seven patients who had been diagnosed with GABA-related hypersomnia (two with IH, two with narcolepsy without cataplexy, and three who had “habitually long sleep”). The researchers gave all of these patients a GABAA-receptor negative allosteric modulator, flumazenil, intravenously. The patients both reported being less sleepy and improved their reaction times on the Psychomotor Vigilance Task (PVT).

In subsequent papers, the Emory researchers reported that clarithromycin, a macrolide antibiotic that is typically used to treat skin and respiratory system infections, also decreased daytime sleepiness in people with GABA-related hypersomnia.

What kind of research study was this new study?

Who were the participants in this study and what did they do?

All of the participants had IH, narcolepsy without cataplexy, or habitually long sleep times. They took either clarithromycin, 500 mg, or placebo at breakfast and at lunch for two weeks. They then took no drug for one week, followed by the opposite drug that they took in the first part of the study—either clarithromycin or placebo—for another two weeks. They came to the Emory research clinic at the same time on the same day of the week for these five weeks, where they completed several questionnaires and performed two PVTs during each visit.

Who were the researchers and what did they do?

Dr. Trotti and her colleagues at Emory University in Atlanta, GA, selected the participants, reviewed the questionnaires, and analyzed the data from the PVTs.

What were the results of the study?

Fifteen women and five men took part in this study. There was no difference in mean reaction time on the PVT at week two between people’s scores when they were taking clarithromycin versus when they were taking placebo. However, significant differences were found on the results of the questionnaires. When taking clarithromycin, the participants had an average four-point lower score on the Epworth Sleepiness Scale, improved scores on the Functional Outcomes of Sleep Questionnaire, and increase in the energy subscale of the SF-36.

Those in the clarithromycin group were more likely to report an altered sense of taste or smell. Otherwise, no differences were found in side effects. These changes are similar to or better than improvements typically seen with modafinil for the treatment of excessive daytime sleepiness associated with narcolepsy or shift work disorder.

What were the authors’ conclusions?

Clearly, the long term use of an antibiotic must be justified by clinical benefit that exceeds these potential risks, as we have elaborated elsewhere. . . This preliminary study suggests that there is a subjective treatment benefit from clarithromycin for idiopathic hypersomnia, narcolepsy without cataplexy, and subjective hypersomnia, consistent with the benefit previously reported in clinical practice. . . “[C]larithromycin might be considered, especially in cases that are otherwise treatment-refractory.

Dr. Toyoda and his colleagues in Japan have described new susceptibility genes–CCR1 and CCR3–for type 1 narcolepsy.

Background

Type 1 narcolepsy (also called narcolepsy with cataplexy) is believed to be the result of a combination of genetic and environmental factors that leads to autoimmune destruction of cells in the brain that make hypocretin. Most, but not all, people with type 1 narcolepsy carry the HLA-DQB1*06:02 allele. However, many people without narcolepsy also have the HLA-DQB1*06:02 allele, which suggests that other factors, likely related to immune function, are involved in the development of narcolepsy.

Who were the participants and what did they do?

All of the people in this study were Japanese living in Japan. Those with narcolepsy had excessive daytime sleepiness and clear-cut cataplexy. They had not been diagnosed with any sleep, neurological, or psychiatric disorder other than narcolepsy. All of them were positive for the HLA-DQB1*06:02 allele. All comparison participants (who did not have narcolepsy) were unrelated healthy people.

Who were the researchers and what did they do?

Dr. Toyoda and his colleagues at the University of Tokyo obtained blood samples from all participants. They first used a genome-wide association study (GWAS) to examine blood samples from 409 people with narcolepsy and 1562 healthy people without narcolepsy (comparison participants) to identify potential single nucleotide polymorphisms (SNPs) that might be associated with narcolepsy. They next confirmed the findings from the GWAS in a different sample of 240 people with narcolepsy and 869 control subjects. One of the SNPs, rs3181077, was located close to the chemokine receptor 1 and 3 (CCR1/CCR3) transcription sites, which suggests it would be related to the expression of these genes. The researchers then measured the messenger RNA of CCR1/CCR3, finding reductions in patients with narcolepsy. To further confirm that this polymorphism affected immune function, the researchers demonstrated that it was also associated with reduced movement of stimulated immune cells.

What are the authors’ conclusions?

Our findings provide evidence for the involvement of impaired CCR1/CCR3 functions in the etiology of narcolepsy.

The contents of this website, including text, graphics and other material, are for informational purposes only. This website is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. The Hypersomnia Foundation does not recommend or endorse any specific tests, physicians, products, procedures, opinions or other information referenced on this website. Reliance on any information on this website is solely at your own risk.

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